Contrast-Enhanced Ultrasound for Abdominal Injuries

Overseen By Rachel Rempell, MD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Allergy to Lumason, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

146 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ultrasound method to detect internal injuries in children with abdominal trauma. It seeks to determine if this ultrasound can serve as a safer and easier alternative to standard CT scans, which have drawbacks such as radiation exposure and higher costs. The procedure uses a special ultrasound contrast agent, Sulfur Hexafluoride Lipid Type A Microspheres (known as Lumason or SonoVue), to enhance imaging. Children who have recently sustained abdominal injuries and are stable (not requiring immediate surgery or large blood transfusions) may be suitable candidates for this trial. As a Phase 4 trial, the research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for Sulfur Hexafluoride Lipid Type A Microspheres used in contrast-enhanced ultrasound?

Research has shown that LUMASON, a special type of ultrasound contrast, is safe for children. Studies indicate it is generally well-tolerated, with most patients not experiencing serious side effects. A review found that the death rate for patients using LUMASON was only 0.03%, which is lower than for those who did not use it.

However, some rare side effects, such as severe allergic reactions, have been reported. While uncommon, these reactions are important to be aware of. Overall, LUMASON has a strong safety record, making it a promising option for detecting abdominal injuries in children without the risks of radiation from a CT scan. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using contrast-enhanced ultrasound with Sulfur Hexafluoride Lipid Type A Microspheres for detecting abdominal injuries because it offers a non-invasive way to enhance imaging. Unlike traditional methods such as CT scans, which involve radiation exposure, this approach uses sound waves and microspheres to provide clearer images of the abdominal area. This technique can potentially lead to quicker, safer, and more accurate diagnosis of internal injuries, which is crucial in emergency settings. Additionally, because it's less invasive and doesn't involve radiation, it poses fewer risks to patients—making it a promising option for both immediate assessment and continuous monitoring.

What evidence suggests that contrast-enhanced ultrasound is effective for detecting abdominal injuries?

Research has shown that contrast-enhanced ultrasound (CEUS) with tiny sulfur hexafluoride bubbles effectively detects injuries in solid organs. In this trial, participants will receive CEUS, which studies have found to be as accurate as CT scans in identifying abdominal injuries, without the radiation risk. Additionally, CEUS can be performed at the bedside, offering speed and convenience. Safety reviews have confirmed its safety for abdominal use, making it a promising alternative to traditional CT scans for assessing abdominal injuries in children. ^{1 6 7 8 9}

Who Is on the Research Team?

Aaron E Chen, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for children who may have internal injuries from blunt force to the belly. They must be stable enough not to need immediate surgery or a massive blood transfusion, and they should already be scheduled for or have had a CT scan. Kids with allergies to Lumason ingredients, heart disease, or penetrating abdominal wounds can't join.

Inclusion Criteria

I have had or might have had a blunt injury to my abdomen.

I have had or will have a CT scan of my abdomen.

I am not in need of an emergency blood transfusion or surgery within the next hour.

Exclusion Criteria

I am allergic to Lumason or its components.

I have a known heart condition from birth or acquired later.

Co-existing penetrating abdominal trauma

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Evaluation

Participants undergo contrast-enhanced ultrasound (CEUS) and conventional CT scan for evaluation of intra-abdominal organ injury

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness of imaging techniques after initial evaluation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]

Trial Overview The study is testing if contrast-enhanced ultrasound using LUMASON can spot internal organ damage in kids with belly injuries as an alternative to CT scans. This could avoid radiation exposure and be done right at the bedside without moving the child.

How Is the Trial Designed?

Group I: Contrast-enhanced ultrasound arm Experimental Treatment 2 Interventions

contrast-enhanced ultrasound

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Published Research Related to This Trial

The study developed new microbubbles using lipids and sulfur hexafluoride (SF6) that significantly enhance the echogenicity of thrombi, improving their visibility during ultrasound imaging.

These targeted microbubbles demonstrated high stability and maintained their characteristics for up to 8 hours, providing a longer diagnostic window compared to traditional nontargeted microbubbles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonging the ultrasound signal enhancement from thrombi using targeted microbubbles based on sulfur-hexafluoride-filled gas. Wang, B., Zang, WJ., Wang, M., et al.[2016]

Intra-articular injection of SonoVue in a study involving 21 rabbits showed no significant adverse effects compared to saline, indicating that it is a safe procedure for joint applications.

While there were mild to moderate histologic changes in the synovial membrane after SonoVue injection, these changes were considered transitory and reversible, suggesting that SonoVue does not cause lasting harm to the joint tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of SonoVue on the synovial membrane in rabbit knees. Domenech, E., Berná-Serna, Jde D., Polo, L., et al.[2019]

Lumason (sulfur hexafluoride microbubbles) has recently been FDA approved for characterizing focal liver lesions (FLL) in both pediatric and adult patients, which is expected to increase its use in routine clinical practice.

The literature indicates that contrast-enhanced ultrasound (CEUS) using Lumason is accurate for FLL characterization, with existing studies comparing its effectiveness to contrast-enhanced computed tomography (CECT) and contrast-enhanced magnetic resonance imaging (CEMRI).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast enhanced ultrasound for focal liver lesions: how accurate is it? Barr, RG.[2019]

The FDA has approved Lumason, a contrast agent for ultrasound, which is expected to enhance the characterization of focal liver lesions in both adults and children, promoting the use of contrast-enhanced ultrasound (CEUS) in clinical practice.

The paper outlines essential guidelines for establishing a CEUS program, including safety measures, indications, contraindications, and procedures for performing and interpreting CEUS exams, ensuring efficient and safe implementation in ultrasound departments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to Develop a Contrast-Enhanced Ultrasound Program. Barr, RG.[2018]

In a study involving 167 contrast-enhanced ultrasound examinations in 137 children with oncologic diseases, only one severe anaphylactic reaction (0.6%) was reported, indicating a generally favorable safety profile for intravenous second-generation ultrasound contrast agents containing sulfur hexafluoride.

No other adverse events were observed, such as changes in vital signs or common side effects like flushing or nausea, suggesting that these agents are well-tolerated in pediatric patients, although ongoing monitoring for potential reactions is recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of intravenous application of second-generation ultrasound contrast agent in children: prospective analysis. Piskunowicz, M., Kosiak, W., Batko, T., et al.[2022]

In a large study of 463,434 contrast-enhanced ultrasound examinations, the use of sulfur hexafluoride microbubbles resulted in a very low adverse event (AE) frequency of only 0.034%, indicating a high safety profile for this contrast agent.

Among the reported AEs, only 4 were classified as serious, and the majority were non-serious, with most reactions occurring within 30 minutes of administration, confirming that sulfur hexafluoride microbubbles are safe for routine clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety findings after intravenous administration of sulfur hexafluoride microbubbles to 463,434 examinations at 24 centers. Shang, Y., Xie, X., Luo, Y., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03473249

Effectiveness of Contrast-Enhanced Ultrasound The primary objective in this study is to determine the sensitivity and specificity of contrast-enhanced ultrasound (CEUS) compared to abdominal Computed ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23611316/

Contrast-enhanced ultrasound using SonoVue® (sulphur ... Objective: To compare the clinical effectiveness and cost-effectiveness of contrast-enhanced ultrasound (CEUS) using SonoVue(®) with that of contrast-enhanced ...

3. fda.gov fda.gov/media/133813/download

CLINICAL REVIEW One AE of necrotizing enterocolitis was reported in a 30-day-old male who was born prematurely at 32 weeks with co-morbidities including cardiac ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9881326/

Is it time to re-think FAST? A systematic review and meta- ... This systematic review and meta-analysis compares the performance of contrast-enhanced ultrasound (CEUS) to conventional ultrasound when used as the initial ...

5. researchgate.net researchgate.net/publication/6824980_The_safety_of_SonovueR_in_abdominal_applications_Retrospective_analysis_of_23188_investigations

The safety of Sonovue® in abdominal applications As a novel ultrasound technique, contrast-enhanced ultrasound (CEUS) is effective in evaluating solid organ injuries, revealing trauma ...

6. lumason.com lumason.com/safety/

Safety Patients who received LUMASON UEA had a mortality rate of only 0.03%—lower than in those who didn't receive a UEA.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11459369/

Contrast-enhanced ultrasound: a comprehensive review ... Piscaglia F, Bolondi L (2006) The safety of Sonovue in abdominal ... Contrast-enhanced ultrasound using sulfur hexafluoride is safe in the pediatric setting.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.7863/ultra.15.11075

Safety of Sulfur Hexafluoride Microbubbles in Sonography ... Contrast-enhanced sonography with sulfur hexafluoride microbubbles had good clinical safety, but rare adverse reactions were observed.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12080674/

Analysis of the Federal Drug Administration Adverse Event ... Anaphylactic reaction was the most common AE reported with sulfur hexafluoride use, and severe AEs including death may be more common than prior large, ...